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Search / Trial NCT05714293

CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jan 27, 2023

Trial Information

Current as of July 01, 2025

Enrolling by invitation

Keywords

Aortic Valve Replacement Aortic Valve Bioprosthesis Coronary Ostia Obstruction Valve In Valve Transcatheter Aortic Valve Implantation Aortic Valve Stenosis Tricuspid Aortic Valve Aortic Valve Regurgitation Ct Coronary Angiogram Transcatheter Aortic Valve Replacement

ClinConnect Summary

Aortic valve stenosis is the most frequent heart valve disease in the adult population. The development of biological prostheses with slower valve degeneration and easier antithrombotic management and changes in the indications for the treatment of this valve disease, have allowed a reduction in the age in which such prostheses are implanted thus leading to a greater use of biological prostheses rather than mechanical ones. In the next few years this will cause a higher rate of structural valve degeneration resulting in stenosis and/or insufficiency. In patients considered to be at high sur...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥ 18 years;
  • Aortic valve stenosis or insufficiency with indication for elective aortic valve replacement with a bioprosthesis;
  • Possible concomitant coronary artery disease with indication for surgical or percutaneous revascularization;
  • CT imaging of the thorax with iodinated contrast agent carried out before surgery;
  • Signed informed consent, inclusive of release of medical information.
  • Exclusion Criteria:
  • Aortic valve replacement in bicuspid valve or endocarditis;
  • Aortic valve replacement associated with surgery of ascending aorta/aortic root;
  • Aortic valve replacement associated with other cardiac valve surgery;
  • Previous cardiac surgery of any kind;
  • Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgment of the investigator;
  • Participation in another clinical trial that could interfere with the endpoints of this study;
  • Pregnant at time of screening;
  • Allergy or hypersensitivity to iodinated contrast agent;
  • End-stage renal disease on dialysis.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Roma, , Italy

Patients applied

0 patients applied

Trial Officials

Massimo Massetti, MD

Principal Investigator

Policlinico Agostino Gemelli

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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